1. Statistical Reference Guide
  2. Measurement systems analysis (MSA)
  3. Precision

Precision

Precision is the closeness of agreement between measured quantity values obtained by replicate measurements on the same or similar objects under specified conditions.

Precision is not a quantity and therefore it is not expressed numerically. Rather, it is expressed by measures such as the variance, standard deviation, or coefficient of variation under the specified conditions of measurement

Conditions of measurement

Many different factors may contribute to the variability between replicate measurements, including the operator; the equipment used; the calibration of the equipment; the environment; the time elapsed between measurements.

Two conditions of precision, termed repeatability and reproducibility conditions are useful for describing the variability of a measurement procedure. Other intermediate conditions between these two extreme conditions of precision are also conceivable and useful, such as conditions within a single laboratory.

Reproducibility

Reproducibility is a measure of precision under a defined set of conditions: different locations, operators, measuring systems, and replicate measurements on the same or similar objects.

Intermediate precision

Intermediate precision (also called within-laboratory or within-device) is a measure of precision under a defined set of conditions: same measurement procedure, same measuring system, same location, and replicate measurements on the same or similar objects over an extended period of time. It may include changes to other conditions such as new calibrations, operators, or reagent lots.

Repeatability

Repeatability (also called within-run precision) is a measure of precision under a defined set of conditions: same measurement procedure, same operators, same measuring system, same operating conditions and same location, and replicate measurements on the same or similar objects over a short period of time.

Variance components

Variance components are estimates of a part of the total variability accounted for by a specified source of variability.

Random factors are factors where a number of levels are randomly sampled from the population, and the intention is to make inferences about the population. For example, a study might examine the precision of a measurement procedure in different laboratories. In this case, there are 2 variance components: variation within an individual laboratory and the variation among all laboratories. When performing the study it is impractical to study all laboratories, so instead a random sample of laboratories are used. More complex studies may examine the precision within a single run, within a single laboratory, and across laboratories.

Most precision studies use a nested (or hierarchical) model where each level of a nested factor is unique amongst each level of the outer factor. The basis for estimating the variance components is the nested analysis of variance (ANOVA). Estimates of the variance components are extracted from the ANOVA by equating the mean squares to the expected mean squares. If the variance is negative, usually due to a small sample size, it is set to zero. Variance components are combined by summing them to estimate the precision under different conditions of measurements.

The variance components can be expressed as a variance, standard deviation (SD), or coefficient of variation (CV). A point estimate is a single value that is the best estimate of the true unknown parameter; a confidence interval is a range of values and indicates the uncertainty of the estimate. A larger estimate reflects less precision.

There are numerous methods for constructing confidence intervals for variance components:
Estimator Description
Exact Used to form intervals on the inner-most nested variance components. Based on the F-distribution.
Satterthwaite Used to form intervals on the sum of the variances. Based on the F-distribution, as above, but uses modified degrees of freedom. Works well when the factors have equal or a large number of levels, though when the differences between them are large it can produce unacceptably liberal confidence intervals.
Modified Large Sample (MLS) Used to form intervals on the sum of variances or individual components. A modification of the large sample normal theory approach to constructing confidence intervals. Provides good coverage close to the nominal level in a wide range of cases.

Estimating the precision of a measurement system

Estimate the precision of a measurement system or procedure.

  1. Select a cell in the dataset.
  2. On the Analyse-it ribbon tab, in the Statistical Analyses group, click Precision, and then click:
    Option Description
    Simple Measurements are made under the same conditions.
    1 Factor Measurements vary by a single random factor.

    Use for performing CLSI EP5 or EP15 in a single laboratory with Run as a factor.

    2 Factor Nested Measurements vary by 2 random factors.

    Use for performing CLSI EP5 in a single laboratory with Day and Run as nested factors.

    3 Factor Nested Measurements vary by 3 random factors.

    Use for performing CLSI EP5 in multiple laboratories with Laboratory, Day, Run as nested factors.

    The analysis task pane opens.
  3. In the Y drop-down list, select the measured quantity variable.
  4. If required: In the Factor A drop-down list, select the first random factor.
  5. If required: In the Factor B nested within Factor A drop-down list, select the second random factor that is nested within the first factor.
  6. If required: In the Factor C nested within Factor B drop-down list, select the third random factor that is nested within the second factor.
  7. Optional: If there are multiple levels of measurement, in the By drop-down list, select the level variable.
  8. Optional: To label the conditions of measurement for the innermost and outermost nested factors, in the Conditions drop-down list, select the labels.
  9. Optional: To customize the detail of the output, select or clear the Abbreviated and Detail check boxes as appropriate.
  10. Optional: To compare the precision against performance requirements:
    • If the allowable imprecision is a constant or proportional value across the measuring interval, under the Allowable imprecision group, select Across measuring interval, and then in the SD / CV edit box, type the SD in measurement units, or the CV as a percentage (suffix with % symbol).
    • If the allowable imprecision varies for each level, under the Allowable imprecision group, select Each level and then in the Allowable imprecision grid, under the SD / CV column, alongside each level, type the SD in measurement units, or the CV as a percentage (suffix with % symbol).
    Note: To compare precision against a performance claim, see Testing precision against a performance claim.
  11. Click Calculate.

Testing precision against a performance claim

Test if the precision matches a performance claim.

You must have already completed the task:

You should use this procedure when you already have a performance claim from a manufacturer's package insert, and you want to test whether your precision is significantly greater than the claim. It is possible for the precision from a study to be greater than the claim, but for the difference to be due to the random error in your study.

  1. Activate the analysis report worksheet.
  2. On the Analyse-it ribbon tab, in the MSA group, click Test.
    The analysis task pane Precision panel opens.
  3. In the Hypothesized imprecision grid, alongside each level, enter the performance claim as the SD in measurement units or the CV as a percentage (suffix with % symbol).
  4. Optional: In the Significance level edit box, type the maximum probability of rejecting the null hypothesis when in fact it is true (typically 5% or 1%) and if required select the Familywise error rate check box.
    Note: CLSI EP15 uses a 5% familywise significance level so the overall significance level is a maximum of 5% regardless of the number of comparisons (for example, for 1 level the significance level is 5%, for 2 levels the significance level is 5%/2 = 2.5% for each level, for 3 levels the significance level is 5%/3 = 1.6% for each level).
  5. Click Recalculate.

Precision profile plot

A precision profile plot shows precision against the measured quantity value over the measuring interval.


precision profileplot

Plotting a precision profile

Plot a precision profile to observe the performance over the entire measuring interval.

You must have already completed the task:
  1. Activate the analysis report worksheet.
  2. On the Analyse-it ribbon tab, in the MSA group, click Profile.
    The analysis task pane Precision Profile panel opens.
  3. In the Precision profile drop-down list, select the measure of precision to plot.
  4. Optional: Select the required variance component check boxes.
  5. Optional: If the measurements spread over a wide interval with many concentrated near zero, select the Logarithmic X-axis scale check box, so they are more clearly visible.
  6. Click Recalculate.

Variance function

A variance function describes the relationship between the variance and the measured quantity value.

The are numerous models that describe the relationship between the variance and measured quantity value across the measuring interval:
Fit Description
Constant variance Fit constant variance across the measuring interval.
Constant CV Fit constant coefficient of variation across the measuring interval.
Mixed constant / proportional variance Fit constant variance at low levels with constant coefficient of variation at high levels.
2-parameter Fir a 2-parameter linear variance function.
3-parameter Fit Sadler 3-parameter variance function – a monotone relationship (either increasing or decreasing) between the variance and level of measurement.
3-parameter alternative Fit Sadler alternate 3-parameter variance function – gives more flexibility than the Sadler standard 3-parameter variance function especially near zero.
4-parameter Fit a Sadler 4-parameter variance function - allows for a turning point near the detection limit.

A variance function can be useful to estimate the limit of detection or limit of quantitation.

Fitting a variance function

Plot a precision profile to observe the performance over the entire measuring interval.

You must have already completed the task:
  1. Activate the analysis report worksheet.
  2. On the Analyse-it ribbon tab, in the MSA group, click Profile.
    The analysis task pane Precision Profile panel opens.
  3. Select the Fit variance function check box.
  4. In the Model drop-down list, select the variance function.
  5. Optional: To estimate the limit of quantitation using functional sensitivity, select the Predict X given CV check box, and then in the edit box, type the CV as a percentage (for example 20%).
  6. Click Recalculate.

Study design

Measurement systems analysis study requirements and dataset layout.

Requirements

  • A quantitative variable.
  • 1 or more optional factor variables indicating the random effects of interest.
  • At least 2 replicates at each level.

Dataset layout

Use a column for the measured variable (Measured value) and optionally a by variable (Level); each row is a separate measurement.

Level (optional) Measured value
120 121
120 118
120 124
120 120
120 116
240 240
240 246
240 232
240 241
240 240

Dataset layout for 1 random factor

Use a column for the measured variable (Measured value), and 1 columns for the random factor (Run), and optionally a by variable (Level); each row is a separate measurement.

Level (optional) Run Measured value
120 1 121
120 1 118
120 1
120 2 120
120 2 116
120 2
120 3
120
240 1 240
240 1 242
240 1
240 2 260
240 2 238
240 2
240 3
240

Dataset layout for 2 random factors

Use a column for the measured variable (Measured value), and 2 columns for the random factors (Day, Run), and optionally a by variable (Level); each row is a separate measurement.

Level (optional) Day Run Measured value
120 1 1 121
120 1 1 118
120 1 1
120 1 2 120
120 1 2 116
120 1 2
120 1 3
120 1
120 2 1 124
120 2 1 119
120 2 1
120 2 2 118
120 2 2 121
120 2 2
120 2 3
120 2
 

Alternate dataset layout

Use multiple columns for the replicates of the measured variable (Measured value) and a by variable (Level), each row is a separate combination of level and factors.

Level Measured value
1 0.7 0.9
2 4.6 4.1
3 6.5 6.9
4 11 12.2
Note: All the above dataset layouts can arrange replicate measurements in a single row rather than in multiple rows.

Statistical Reference Guide v6.15